De-resuscitation Informed by Ultrasound for Patients With Sepsis

Sepsis Clinical Trial

— DRI-US  

Official title:

Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921319
• Other study ID #: 1694487-1
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: March 2021
• Source: The Miriam Hospital
• Contact: Christopher F Allison, MD
• Phone: 401-793-4501
• Email: callison[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.

Description:

Physicians can assess venous congestions with point of care ultrasound of intraabdominal veins using the venous excess in ultrasound score (VExUS), which has been shown to predict the harmful effects of volume overload. We seek to determine if VExUS-guided deresuscitation reduces the fluid balance in critically ill patients with sepsis as compared to usual care. This score compiles findings from the inferior vena cava, hepatic vein Doppler waveform, portal vein Doppler waveform, and intrarenal vein Doppler waveform:

Grade 0: IVC < 2cm, normal pattern in flow patterns of hepatic, portal, and intrarenal veins Grade 1: IVC ≥ 2cm, normal patterns or mild abnormalities in flow patterns of hepatic, portal, and intrarenal veins.

Grade 2: IVC ≥ 2cm, severe venous flow pattern in one among hepatic, portal, and intrarenal veins.

Grade 3: IVC ≥ 2cm, severe venous flow pattern in multiple among hepatic, portal, and intrarenal veins.

After informed consent, subjects will be randomized in a 1:1 ratio to the VExUS-guided intervention arm vs control arm. Subjects in both arms will undergo daily ultrasound, and the investigator will calculate the VExUS immediately after ultrasounds are obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria:

1. Temperature of > 38 C or < 36 C

2. Heart rate of > 90/min

3. Respiratory rate of > 20/min or PaCO2 < 32 mm Hg

4. White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands. 2. Known or suspected infection at the time of screening 3. Admission to the ICU for <24 hours

Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.

Exclusion Criteria:

1. Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis

2. Patients with severe chronic kidney disease (estimated glomerular filtration rate<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).

3. Age < 18 years

4. Active atrial fibrillation or atrial flutter

5. Hemodynamic instability due to active hemorrhage

6. Acute cerebral vascular event

7. Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)

8. Acute pulmonary edema

9. Status asthmaticus

10. Drug overdose

11. Injury from burn or trauma

12. Status epilepticus

13. Indication for immediate surgery

14. Received CPR within 24 hours of enrollment

15. Pregnancy

16. Incarceration.

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Septic Shock
• Toxemia
• Volume Overload

Intervention

Diagnostic Test:
• VExUS score
The care team will be informed of the VExUS immediately after the ultrasound is performed and given a suggested target for the following 24 hours as follows: VExUS 0: "The patient will likely tolerate more fluid if clinically needed." VExUS 1: "The patient has evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis." VExUS 2-3: "The patient has evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis." If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge	Total fluid balance (ins minus outs)	At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary	Incidence of Acute Kidney Injury	acute kidney injury as defined by KDIGO criteria	At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary	Incidence of respiratory failure	Incidence of respiratory failure defined by intubation rates, ventilator free days, ventilator days, use of non-invasive positive pressure ventilation, and use of high flow oxygen	At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary	Change in SOFA score	Change in Sequential Organ Failure Assessment (SOFA) score during study period, on scale of 0-48, with higher values being a worse outcome	At 5 days post ICU admission or ICU discharge, whichever comes first
Secondary	28-day and in-hospital mortality	All-cause mortality.	28 days and during hospital admission up to 24 weeks
Secondary	ICU discharge fluid balance	Cumulative admission fluid balance at time of ICU discharge.	From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first
Secondary	Daily Sonographic B Line Measurement	Measured by counting sonographic B lines in 16 lung zones	study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first